Intended Use: The AMPLATZER™ Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
Warnings: The safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.
MRI Safety Information:
|A patient with the Amplatzer™ Vascular Plug II may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.|
|Device Name||Amplatzer™ Vascular Plug II|
|Static Magnetic Field Strength (B0)||1.5 T or 3.0 T|
|Maximum Field Spatial Gradient||19T/m (1900 gauss/cm)|
|RF Excitation||Circularly Polarized (CP)|
|RF Transmit Coil Type||Body Coil|
|Operating Mode||Normal Operating Mode|
|Maximum Whole Body SAR||2.0W/kg (Normal Operating Mode)|
|Maximum Head SAR||N/A|
|Scan Duration||2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning|
|MR Image Artifact||The presence of this implant may produce an image artifact.|
Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.
State of California (USA) Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.